Responsible for providing quality assurance support for quality system requirements associated with: pharmaceutical products, medical devices, combination products and biologics. Specific areas of support may include, Product Complaints, potential quality events/product shortage execution, Supplier Controls, Product Quality Review, Risk Management, Agency inspections/internal audits, CAPA, and overall Quality Manual requirements. This position will ensure that all product, process or system related quality activities supporting the business at the affiliate from receipt of final product through distribution are in compliance with Corporate, governmental, and local regulations and requirements.
•Assist with the integration and support of quality regulations: drug, biologics, device and/or combination products.
•Assist in the design of effective quality systems, procedures and/or processes within cross functional teams to ensure compliance as well as efficiency throughout our quality systems. Evaluate, analyze and trend quality indicators, data and performance metrics; communication and elevation of affiliate compliance status and risk while maintaining a continuous improvement objective.
•Partner, coordinate and support activities related to product actions in the affiliate.
•Assist project teams in planning, preparation, review and approval of quality documentation. Coordinate the Quality Management Review process.
•Perform assessments to determine compliance to processes, procedures and regulations to identify potential gaps and mitigate and implement improvements. Support internal and external quality inspections and audits including reporting, response to observations and tracking of action plans.
•Participate in training and education programs for various aspects of quality assurance.
•Coordinate and investigate quality events such as deviations, non conformances, product complaints and corresponding action plans including decisions.
•Quality management of supplier qualification program including performance monitoring for key suppliers.
•Ensure metrics and KPIs are being met.
•Represent affiliate QA in regional, global and cross functional teams, projects and programs, as assigned by management.
- Bachelor’s Degree in Business Administration, Sciences or Engineering.
- Six (6) years of experience in Quality area position, with hands on experience in the following areas: Project Management, Scheduling and Inventory Control.
- The incumbent must have hands-on experience in Excel, Word, Power Point, etc.
- Knowledge of statistics is desirable.
- Must be familiar with the Good Manufacturing Practices and Good Laboratory Practices
AbbVie is committed to operating with integrity, driving innovation, transforming lives, serving our community, and embracing diversity and inclusion. It is AbbVie’s policy to employ qualified persons of the greatest ability without discrimination against any employee or applicant for employment because of race, color, religion, national origin, age, sex (including pregnancy), physical or mental disability, medical condition, genetic information, gender identity or expression, sexual orientation, marital status, status as a protected veteran, or any other legally protected group status.